TRUEread
GUDID 10087701403511
TRUEread 50 Blood Glucose Test Strips
TRIVIDIA HEALTH, INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 10087701403511 |
| NIH Device Record Key | 7ce09f91-118c-4e1e-b166-0b1044242813 |
| Commercial Distribution Discontinuation | 2017-10-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | TRUEread |
| Version Model Number | TRUEread 50 Blood Glucose Test Strips |
| Company DUNS | 151810868 |
| Company Name | TRIVIDIA HEALTH, INC. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00021292002060 [Package] Contains: 00021292008659 Package: Box [1 Units] Discontinued: 2017-10-12 Not in Commercial Distribution |
| GS1 | 00021292002282 [Package] Contains: 00021292008659 Package: Box [1 Units] Discontinued: 2017-05-16 Not in Commercial Distribution |
| GS1 | 00021292007751 [Unit of Use] |
| GS1 | 00021292008659 [Primary] |
| GS1 | 00087701403514 [Package] Contains: 00021292008659 Package: Box [1 Units] Discontinued: 2017-10-12 Not in Commercial Distribution |
| GS1 | 10021292002067 [Package] Contains: 00021292002060 Package: Case [24 Units] Discontinued: 2017-10-12 Not in Commercial Distribution |
| GS1 | 10021292002289 [Package] Contains: 00021292002282 Package: Case [24 Units] Discontinued: 2017-05-16 Not in Commercial Distribution |
| GS1 | 10087701403511 [Package] Contains: 00087701403514 Package: Case [24 Units] Discontinued: 2017-10-12 Not in Commercial Distribution |
| GS1 | 20021292002064 [Package] Contains: 00021292002060 Package: Case [360 Units] Discontinued: 2017-10-12 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042080
FDA Product Code
| NBW | System, Test, Blood Glucose, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-11-01 |
| Device Publish Date | 2016-09-20 |
Devices Manufactured by TRIVIDIA HEALTH, INC.
| 10010939719444 - TRUE METRIX | 2024-08-30 sunmark TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER |
| 10010939722444 - TRUE METRIX | 2024-08-30 sunmark TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY |
| 10010939742442 - TRUE METRIX AIR | 2024-08-30 sunmark TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METER |
| 00021292005849 - TRUEplus | 2024-08-30 TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.5cc insulin |
| 50096295125394 - TRUEplus | 2024-08-30 TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 1.0cc insulin |
| 10021292007192 - TRUE METRIX | 2024-08-30 sunmark TRUE METRIX PRE-PACK |
| 10021292015036 - TRUENESS | 2024-04-11 TRUENESS Blood Glucose Meter |
| 10021292015043 - TRUENESS AIR | 2024-04-11 TRUENESS AIR Blood Glucose Meter |
Trademark Results [TRUEread]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUEREAD 77172875 3447923 Dead/Cancelled |
NIPRO DIAGNOSTICS, INC. 2007-05-04 |
 TRUEREAD 77172865 3447922 Dead/Cancelled |
NIPRO DIAGNOSTICS, INC. 2007-05-04 |
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